BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 2559621 · Received April 18, 2012

    Report

    Report Number
    1821850-2012-00002
    Event Type
    Malfunction
    Date Received
    April 18, 2012
    Date of Event
    September 19, 2012
    Report Date
    April 18, 2012
    Manufacturer
    MICHIGAN INSTRUMENTS, INC.
    Product Code
    DRM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RETURNED TO MICHIGAN INSTRUMENTS AND A THOROUGH EVALUATION WAS COMPLETED. THE COMPLAINT COULD NOT BE CONFIRMED. UPON ARRIVAL, THE UNIT WAS GIVEN A FUNCTIONAL TEST AND OPERATED TO ITS SPECIFICATIONS. ADDITIONAL PROBLEMS WERE DISCOVERED THAT DID NOT AFFECT THE PROPER FUNCTION OF THE UNIT. THERE WAS DAMAGE TO THE MASSAGER PAD AND A GAS LEAK FOUND. THE UNIT WAS REPAIRED AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    A PT WAS BROUGHT IN TO THE EMERGENCY ROOM IN CARDIAC ARREST WITH A PROLONGED DOWN TIME. THE LIFE-STAT WAS APPLIED. IT WAS NOTED THAT THE BATTERY LIGHT HAD COME ON AND OPERATORS CHANGED THE BATTERIES DURING A PULSE CHECK. AFTER THE BATTERY CHANGE IT WAS REPORTED THAT THE UNIT WOULD NOT RESTART. THE LIFE-STAT WAS IMMEDIATELY REMOVED AND MANUAL CPR WAS CONTINUED. THE PT WAS NOT REVIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE-STAT CARDIOPULMONARY RESUSCITATOR DRM MICHIGAN INSTRUMENTS, INC. 1008

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR